MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 72" SMALLBORE EXT SET W/CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Model Number	B2140
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.Without the returned device a probable cause is unable to be determined.
Event or Problem Description
The event occurred at 0652 am and involved a 72" smallbore ext set w/clamp, rotating luer that the customer reported cracked tubing and the tubing full of air.It was reported that the lipids were changed at 0600 split bag, and at 0652 am the lipids were found to be leaking onto the floor.A small amount of air was aspirated out of the peripherally inserted central catheter (picc) extension and flushed with saline.The air did not get to the baby and the lipids tubing was changed to address the issue.There was patient involvement, however, no serious injury, and no death or potential death.

• Brand Name: 72" SMALLBORE EXT SET W/CLAMP, ROTATING LUER
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 11821998
• Report Number: 9617594-2021-00159
• Device Sequence Number: 1058680
• Product Code: FMG
• UDI-Device Identifier: 00887709003378
• UDI-Public: (01)00887709003378(17)260101(10)5154974
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2026
• Device Model Number: B2140
• Device Catalogue Number: B2140
• Device Lot Number: 5154974
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1